Supplementary Materials for Reviewers

The present dataset comprises supplementary materials for the study "Retrospective analysis of post-marketing safety data for bimekizumab: A real-world pharmacovigilance study". These materials include additional tables and figures that provide detailed data and methodological information in support of the analysis. Supplementary Materials Figures: Supplementary Figure 1. Signal detection of AEs related to bimekizumab. Supplementary Figure 2. Time-to-onset of bimekizumab-related adverse events and comparison of cumulative incidence between patients with serious and non-serious outcomes. (A) Time-to-onset of bimekizumab-related AEs based on 381 reports. (B) Time-to-onset of bimekizumab-related AEs in patients with serious outcomes (325 reports). (C) Time-to-onset of bimekizumab-related AEs in patients with non-serious outcomes (56 reports). (D) The cumulative incidence of adverse events differed significantly between patients with serious and non-serious outcomes following bimekizumab treatment (log-rank test, P = 0.031). Supplementary Figure 3. All positive signals at the PT level based on serious/non-serious outcomes in patients. Supplementary Figure 4. Volcano plots illustrate all positive PT signals associated with bimekizumab across different stratifications, including risk signals related to gender (A), age (B), body weight (C), and reporter type (D). Supplementary Figure 5. Analyze the risk differences of positive signals across different populations: (A) gender differences; (B) age differences; (C) weight differences; (D) reporter differences. Supplementary Figure 6. Cumulative incidence of adverse events across subgroups. No significant differences in the cumulative incidence of adverse events were observed across gender (A), age (B), weight (B), or reporter (D) in bimekizumab-treated patients (log-rank test, P > 0.05). Supplementary Figure 7. A comprehensive summary of all positive signals at the PT level was provided when reporting secukinumab as a comparator for bimekizumab. Tables: Supplementary Table 1. Four major algorithms used for signal detection. Supplementary Table 2. A rating scale assessing clinical priority of disproportionality signals.本数据集为研究《倍科单抗（bimekizumab）上市后安全性数据回顾性分析：一项真实世界药物警戒研究》的补充材料，包含可为该分析提供详细数据与方法学支撑的额外表格与图件。 ### 补充材料 #### 补充附图 1. 补充图1：倍科单抗相关不良反应（adverse event, AE）的信号检测。 2. 补充图2：倍科单抗相关不良反应的发生时间，以及严重与非严重结局患者间的累积发生率比较。(A) 基于381份报告的倍科单抗相关不良反应发生时间；(B) 存在严重结局的患者（325份报告）的倍科单抗相关不良反应发生时间；(C) 存在非严重结局的患者（56份报告）的倍科单抗相关不良反应发生时间；(D) 倍科单抗治疗后，严重与非严重结局患者的不良反应累积发生率存在显著差异（对数秩检验，P=0.031）。 3. 补充图3：基于患者严重/非严重结局的所有首选术语（Preferred Term, PT）水平阳性信号。 4. 补充图4：火山图展示了倍科单抗在不同分层下的所有首选术语水平阳性信号，包括与性别（A）、年龄（B）、体重（C）及报告者类型（D）相关的风险信号。 5. 补充图5：分析不同人群中阳性信号的风险差异：(A) 性别差异；(B) 年龄差异；(C) 体重差异；(D) 报告者差异。 6. 补充图6：不同亚组的不良反应累积发生率。倍科单抗治疗患者中，不同性别（A）、年龄（B）、体重（C）及报告者（D）亚组间的不良反应累积发生率无显著差异（对数秩检验，P>0.05）。 7. 补充图7：当以司库奇尤单抗（secukinumab）作为倍科单抗的对照药物时，提供了所有首选术语水平阳性信号的综合汇总。 #### 补充附表 1. 补充表1：用于信号检测的四种主要算法。 2. 补充表2：评估非比例性信号临床优先级的评分量表。